Samantha DiGrande


Mergers, Acquisitions, and Rebates: The Latest Healthcare Shakeups

March 30, 2018

Walmart is reportedly in early talks with Humana; Aetna says that it will automatically apply pharmacy rebates at the time of drug sales for its fully insured commercial plan members; and the American Antitrust Institute is raising concerns about 2 proposed acquisitions.

FDA Fears USP's Monograph Changes Could Discourage Biosimilars

March 29, 2018

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

Anti-VEGF Drugs Not Associated With Increased Risk of AEs in Eye Diseases

March 28, 2018

Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology.

European Council Hints That United Kingdom Will Be Excluded from EMA

March 27, 2018

UK Prime Minister Theresa May has called for the United Kingdom to remain a member of the European Medicines Agency (EMA), but the European Council says that "The Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU Institutions."

Study: Rituximab Associated With More AEs Than Other Infusions in Pediatric Patients

March 26, 2018

Intravenous infusion therapy has become critical for the treatment and maintenance of many pediatric rheumatic diseases, such as juvenile idiopathic arthritis, systemic lupus erythematosus, and inflammatory bowel disease-associated arthritis. Recently, researchers conducted a retrospective review of all pediatric patients given infusions at the University of Alabama at Birmingham from 2012 to 2015.

Trump Promises "Major" News on Drug Pricing "In About a Month"

March 24, 2018

Earlier this week, President Donald Trump made a speech in New Hampshire to discuss the administration’s efforts in combatting both the opioid crisis and high drug prices. In the speech, Trump alluded to a possible press conference in the near future that would discuss potential proposals in reducing prescription drug prices.

CHMP Grants Sandoz Positive Opinion for Proposed Infliximab Biosimilar

March 23, 2018

Novartis division Sandoz announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the marketing authorization of biosimilar infliximab.

AHIP's New CEO Supports Reducing Drug Costs Through Robust Biosimilar Market

March 22, 2018

Insurance lobbying group, America’s Health Insurance Plans (AHIP), recently named Matt Eyles as its next president and CEO beginning June 1. Eyles, currently AHIP’s chief operating officer, recently gave a statement about his priorities for the organization once he begins his tenure.

Dr Angus Worthing Addresses Recent Physician Letter Sent to HHS

March 21, 2018

In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, discussed the letter recently sent to HHS addressing physician concerns with proposed legislation.